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The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer (CQGOG0102)

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ClinicalTrials.gov Identifier: NCT04409860
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Dongling Zou, Chongqing University Cancer Hospital

Study Description
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Brief Summary:
The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: CCRT Drug: Paclitaxel, Cisplatin Not Applicable

Detailed Description:

  1. Objective:

    To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.

  2. Patients:

    1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
    2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）
    3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
  3. Methods:

The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: control group
In this group, observation is given after CCRT.
 Radiation: CCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Other Name: control group: CCRT + observation
Experimental: trial group
In this group, adjuvant chemotherapy is given after CCRT.
 Radiation: CCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Other Name: control group: CCRT + observation

Drug: Paclitaxel, Cisplatin
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Other Name: trial group: CCRT + adjuvant chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]
    Progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 5 years ]
    5 years overall survival

  2. ORR [ Time Frame: 3 months ]
    To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
  2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
  3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
  4. ECOG<2
  5. Expected survival is longer than six months
  6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
  7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
  8. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial

Exclusion Criteria:

  1. Activity or uncontrol severe infection
  2. Liver cirrhosis, Decompensated liver disease
  3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
  4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
  5. Have suffered or combined with other malignant tumor
  6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
  7. A history targeted therapy or pelvic artery embolization
  8. Artery-enous thrombosis within 6 months
  9. Patients with autoimmune diseases
  10. Complications, need to be treatment with drugs which may lead to liver or kidney injury
  11. Patients with disease progression after chemoradiation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409860


Contacts
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Contact: Dongling Zou, M.D. 13657690699 cqzl_zdl@163.com

Locations
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China, Chongqing
Chongqing Cancer Hospital Recruiting
Chongqing, Chongqing, China, 400030
Contact: Dongling Zou, M.D.    13657690699    cqzl_zdl@163.com   
Principal Investigator: Dongling Zou, M.D.         
Sponsors and Collaborators
Chongqing University Cancer Hospital
Investigators
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Principal Investigator: Dongling Zou, M.D. Chongqing University Cancer Hospital
More Information
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Publications:

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Responsible Party: Dongling Zou, Associated Director, Chongqing University Cancer Hospital
ClinicalTrials.gov Identifier: NCT04409860    
Other Study ID Numbers: CQGOG0102
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dongling Zou, Chongqing University Cancer Hospital:
Locally adcanced
CCRT
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
 Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action